Celltrion Healthcare: Switching to Remsima®▼ (infliximab) from originator has no negative effect on safety or efficacy in 10 real-world studies
Real-world studies with nearly 600 inflammatory bowel disease (IBD) patients in eight countries show comparable efficacy and safety following a switch to biosimilar infliximab from originator infliximab.1-10 These studies, presented at the 11th Congress of the European Crohn’s and Colitis Organisation (ECCO), further support the appropriate switching of patients to Remsima®, a cost-effective alternative to originator infliximab, and build on the wealth of real-world evidence of the safety and efficacy of Remsima® accumulated since its launch a year ago.
As physician experience with biosimilar infliximab has grown, so has confidence in monoclonal antibody biosimilars. The results of a survey of ECCO members presented at the ECCO congress show that only 19.5% of respondents feel little or no confidence in the use of biosimilar monoclonal antibodies compared to 61% of respondents to a previous version of the survey undertaken in 2013.11 The survey also shows that positive switching studies with biosimilar infliximab have helped to reassure physicians about switching from the originator, with 44.4% of respondents considering the originator and biosimilar to be interchangeable, compared with only 6% in the 2013 survey.
Professor Silvio Danese, head of the IBD Center at the Istituto Clinico Humanitas and lead author of the survey, said: “Biosimilar infliximab was the first monoclonal antibody to become available so there was some understandable trepidation around the time of launch. However, as people have been able to use the treatment, and with the large number of real-world and post-marketing studies now available, increasing numbers of clinicians are confident to use monoclonal antibody biosimilars. It is important that post-marketing and longer term studies with biosimilar infliximab are reported in order to further reassure clinicians and patients about biosimilars.”
The positive results of the biosimilar infliximab switching studies are further supported by two long-term follow up studies presented today at a Celltrion Healthcare satellite symposium. The extension studies of PLANETAS12 and PLANTETRA13 – the phase 3 trials that supported the approval of Remsima® – were performed to investigate the efficacy and safety of maintenance treatment with Remsima® over two years as well as the efficacy and safety of switching to Remsima® from originator infliximab for one year. Clinical efficacy, immunogenicity and safety were highly comparable between the maintenance and switch groups in both extension studies. Importantly, there were no signs of altered efficacy, safety or immunogenicity profiles following the switch to Remsima® from the originator. Furthermore, the proportion of immunogenicity-related safety events was similar between maintenance and switched rheumatoid arthritis and ankylosing spondylitis patients.
Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “We know that physicians value real-world as well as clinical evidence and have worked hard to ensure these data are available. We now have a remarkable volume of data showing the comparable safety and efficacy of Remsima® in both treatment-naïve patients and those who have been switched to Remsima® from originator infliximab. We’re delighted to see a corresponding growth in physician confidence with monoclonal antibody biosimilars, and in willingness to switch to a biosimilar from the originator. This suggests that more patients will get the chance to benefit from biological therapies, particularly for conditions that require chronic treatment such as IBD.”
Notes to editors:
About the switching studies
|Abstract||Title||Authors||# of switched patients|
|DOP029||Outcomes of a managed switching programme changing IBD patients established on originator infliximab to biosimilar infliximab||F. Cummings, et al.||
|DOP030||Elective switching from Remicade® to biosimilar CT-P13 in Inflammatory Bowel Disease patients: A prospective observational cohort study||L. Smits, et al.||
(CD: 57 UC: 24 Unclassified IBD: 2)
|DOP032||Switching of patients with Inflammatory Bowel Disease from original infliximab (Remicade®) to biosimilar infliximab (Remsima®) is effective and safe||M. Kolar, et al.||
(CD: 56, UC: 18)
|P329||Infliximab biosimilar in the treatment of Inflammatory Bowel Disease: A Japanese single cohort observational study||S. Hamanaka, et al.||
(CD: 2, UC: 1)
|P449||Efficacy and safety of switching between originator and biosimilar infliximab in patients with Inflammatory Bowel Disease in practical clinic: Results to 6 months||L. Díaz Hernández, et al.||
(CD: 62, UC: 10)
|P452||Safety and efficacy of infliximab biosimilar (Remsima©) in Crohn’s Disease patients in clinical practice: Results after 6 months’ treatment||M.F. Guerra Veloz, et al.||
|P544||Prospective observational study on IBD patients treated with infliximab biosimilars: Preliminary results of the PROSIT-BIO cohort of the IG-IBD||N. Manetti, et al.||
|P600||Safety and efficacy of infliximab biosimilar (Remsima©) in Ulcerative Colitis disease patients in clinical practice: Results after 6 months treatment||M.F. Guerra Veloz, et al.||
|P617||Immunogenicity after switching from reference infliximab to biosimilar in children with Crohn disease||J. Sieczkowska, et al.||
|P655||Biosimilar infliximab CT-P13 treatment in patients with Inflammatory Bowel Diseases: A one year, single-center retrospective study||T. Hlavaty, et al.||
(CD: 10, UC: 2)
Further data for biosimilar infliximab presented at the 11 th Congress of ECCO
- OP003 P.A. Golovics, et al. Predicting short and medium-term efficacy of the biosimilar infliximab: trough levels/ADAs or clinical/biochemical markers play a more important role?
- DOP010 A. Bálint, et al. Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort.
- DOP028 K. Gecse, et al. Efficacy and safety of biosimilar infliximab after one year: results from a prospective nationwide cohort.
- DOP031 R. Bor, et al. Efficacy of infliximab biosimilar CT-P13 therapy on mucosal healing in ulcerative colitis – data from two Central European countries.
- DOP033 B. Lovasz, et al. Immunogenicity profile and predictors of TLs and ADA development of biosimilar infliximab during the first 6 months of the therapy: results from a prospective nationwide cohort.
- P311 D. Duricova, et al. No difference in immunogenicity of the original and biosimilar infliximab in patients with inflammatory bowel disease: Short-term results.
- P327 L. Carvalho Lourenço, et al. Biosimilar infliximab in real-life Crohn’s disease’s anti-TNF alpha naïve patients: a comparative observational cohort study (SIMRECRO study).
- P382 R. Muhammed, et al. Comparison of efficacy and safety of biosimilar infliximab to originator infliximab in children with inflammatory bowel disease.
- P484 P. Lakatos, et al. Access to biologics and biosimilars across 11 EU countries.
- P495 M. Bortlik, et al. Biosimilar infliximab is effective and safe in inflammatory bowel disease patients naïve to antiTNF therapy: a tertiary centre experience.
- P513 E. Zagorowicz, et al. Comparison of infliximab the originator and biosimilars in treatment of Crohn’s Disease: a Polish cohort study.
- P519 M. Kaniewska, et al. Efficacy and safety of biosimilar of infliximab (Inflectra) in adult patients with Crohn’s disease during one year of treatment followed by 6 months of observation – one centre retrospective study.
- P530 J. Sieczkowska, et al. Efficacy of biosimilar infliximab induction therapy in paediatric patients with Crohn’s Disease –1.5 years of experience.
- P577 N. Turk, et al. Croatian database from 5 centers – efficacy and safety of infliximab biosimilar in treatment of IBD patients.
- P645 M. Kaniewska, et al. Efficacy and safety of biosimilar of infliximab in rescue therapy in adult patients with severe ulcerative colitis.
About inflammatory bowel diseases
Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life. They affect an estimated 2.5-3 million people in Europe;14 CD affects about three people per 1,000 and UC about 5 people per 1,000.16
IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.17
About biosimilar infliximab
The biosimilar infliximab developed and manufactured by Celltrion, Inc. is the world’s first biosimilar monoclonal antibody to be approved by the European Medicines Agency (EMA) for treatment of eight autoimmune diseases. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. It is currently being reviewed by the U.S. FDA with the FDA Arthritis Advisory Committee recommending approval of all indications of Celltrion’s biosimilar infliximab in February 2016.
About Celltrion Healthcare
Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries, including both developed and emerging markets. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA’s cGMP and the EMA’s GMP standards. For more information please visit: www.celltrionhealthcare.com/
Celltrion Healthcare has established a vast distribution network of partners and experts who have in-depth knowledge and experience in their local markets. In European markets, Celltrion Healthcare is in partnership with the following companies:
- Astro Pharma: Austria
- Biogaran: France and Monaco
- DEMO S.A.: Cyprus
- Egis: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Moldova, Bulgaria, Czech Republic, Latvia, Lithuania, Poland, Romania, Slovakia, Russia, Ukraine, Uzbekistan and Hungary.
- Hospira: Europe
- Iceland: Portfarma
- Kern Pharma: Spain
- Medical Logistics: Malta
- Mundipharma: Belgium, Germany, Italy, Luxembourg, the Netherlands and the UK (Napp)
- Oktal Pharma d.o.o: Slovenia, Croatia, Bosnia-Herzegovina and Serbia
- Orion: Denmark, Estonia, Finland, Norway, and Sweden
- PharmaKern: Portugal
- Pinewood: Ireland
- Switzerland: iQone Healthcare
1 Cummings F, et al. Outcomes of a managed switching programme changing IBD patients established on originator infliximab to biosimilar infliximab. 11th Congress of ECCO. DOP029.
2 Smits L, et al. Elective switching from Remicade® to biosimilar CT-P13 in Inflammatory Bowel Disease patients: A prospective observational cohort study. 11th Congress of ECCO. DOP030.
3 Kolar M, et al. Switching of patients with Inflammatory Bowel Disease from original infliximab (Remicade®) to biosimilar infliximab (Remsima™) is effective and safe. 11th Congress of ECCO. DOP032.
4 Diaz Hernández L, et al. Efficacy and safety of switching between originator and biosimilar infliximab in patients with Inflammatory Bowel Disease in practical clinic: Results to 6 months. 11th Congress of ECCO. P449.
5 Sieczkowska J, et al. Immunogenicity after switching from reference infliximab to biosimilar in children with Crohn disease. 11th Congress of ECCO. P617.
6 Hamanka S, et al. Infliximab biosimilar in the treatment of inflammatory bowel disease: a Japanese single-cohort observational study. 11th Congress of ECCO. P329.
7 Guerra Veloz MF, et al. Safety and efficacy of infliximab biosimilar (Remsima) in Crohn’s disease patients in clinical practice: results after 6 months of treatment. 11th Congress of ECCO. P452.
8 Fiorino G, et al. Prospective observational study on inflammatory bowel disease patients treated with infliximab biosimilars: preliminary results of the PROSIT-BIO cohort of the IG-IBD. 11th Congress of ECCO. P544.
9 Guerra Veloz MF, et al. Safety and efficacy of infliximab biosimilar (Remsima) in ulcerative colitis disease patients in clinical practice: results after 6-months treatment. 11th Congress of ECCO. P600.
10 Hlavaty T, et al. Biosimilar infliximab CT-P13 treatment in patients with inflammatory bowel diseases: a 1-year, single-centre retrospective study. 11th Congress of ECCO. P655.
11 Danese S, et al. Has IBD specialists’ awareness of biosimilar monoclonal antibodies changed? Results from a survey among ECCO members. 11th Congress of ECCO. P312.
12 Park W, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10):1605-12. Available at: ard.bmj.com/content/early/2013/05/16/annrheumdis-2012-203091.full [accessed March 2016].
13 Yoo D H, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613-20. Available at: ard.bmj.com/content/early/2013/05/20/annrheumdis-2012-203090.full.pdf [accessed March 2016].
14 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
JPMorgan Chase Bank announces the placement of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 19:40 | Pressemelding
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the placement of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest. The Bonds will be issued with an issue price of 100% and will redeem at par on 30 December 2020. The initial exchange price (the “Initial Exchange Price”) will
Boston Capital Announces Closing of Boston Capital Income & Value U.S. Apartment Fund17.7.2018 14:00 | Pressemelding
Boston Capital, the third largest owner of apartments in the U.S. with over $19.6 billion invested, is pleased to announce the final investor closing of Boston Capital Income and Value U.S. Apartment Fund (“BCIV”). BCIV, a discretionary multi-investor Luxembourg based fund vehicle, includes financial institutions, insurance companies, pensions, and family offices among its investors and will acquire over $350 million in apartment properties throughout the U.S. “We are very pleased to close BCIV, the latest in a succession of institutional investment vehicles through Boston Capital’s conventional apartment investment arm, Boston Capital Real Estate Partners (“BCRE”),” said Jeff Goldstein, COO and Director of Real Estate at Boston Capital. The Fund generates high current dividends and capital growth by acquiring and renovating Class B apartment properties located in major and secondary U.S. markets and by targeting a renovated rental price point well below new construction rates, which a
Amobee Wins Auction Process to Acquire Videology Assets17.7.2018 13:13 | Pressemelding
Singtel subsidiary Amobee, a leading global digital marketing technology company serving brands and agencies, today announced that it has emerged as the winner in the court supervised auction to acquire certain assets from Videology, a software provider for advanced TV and video advertising, for purchase price of approximately US$101 million1. The purchase price is subject to adjustments for accounts receivable at closing, estimated to be approximately US$20.9 million. The acquisition, following Videology’s voluntary Chapter 11 restructuring proceedings, includes Videology’s technology platform, intellectual property and certain other assets of estimated net book value of US$5.3 million2. Over the past decade, Videology has emerged as a leading provider of software that empowers advertisers and publishers to use data to optimize campaigns and spend across digital platforms and television. The addition of Videology’s capabilities will be a further boost to Amobee’s omni-channel platform
Lenovo Leaps Forward with Next-Generation ThinkAgile Composable Cloud Platform17.7.2018 12:00 | Pressemelding
Lenovo Data Center Group (HKSE: 992) (ADR: LNVGY), one of the fastest growing hyperconverged infrastructure (HCI) vendors according to IDC, – with HCI revenue growing at almost twice the market growth rate in Q1 2018 (149.1% compared to 76.3%)—is further expanding its ThinkAgile portfolio to provide an innovative solution for customers who desire the agility of the public cloud and the security of a private cloud. To address this growing customer trend, Lenovo – together with Cloudistics – has developed the ThinkAgile CP Series composable cloud platform, a ‘cloud-in-a-box’ that offers all of the conveniences and ease-of-use of a public cloud environment secured behind the customer’s own data center firewall. Lenovo ThinkAgile CP Series – with fully-integrated infrastructure, application marketplace and end-to-end automation of software-defined network, compute and storage – delivers a turnkey cloud experience that can be easily and centrally managed from anywhere through a software-as-
JPMorgan Chase Bank launches offering of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 12:00 | Pressemelding
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the launch of an offering of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of up to approximately USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Issuer is rated A+ (Stable outlook) by Standard & Poor’s, Aa3 (Stable outlook) by Moody’s and AA (Stable outlook) by Fitch. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest.
Greene Tweed Achieves Nadcap Accreditation for Non-Metallic Materials Testing17.7.2018 11:01 | Pressemelding
Greene Tweed’s Central Engineering (CE) Materials Test Lab recently completed its final Nadcap accreditation audit for Non-Metallic Materials Testing (NMMT) of composite materials. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180717005200/en/ Greene Tweed Achieves Nadcap Accreditation (Photo: Greene Tweed) In support of Aerospace’s strategic initiative, this positions Greene Tweed as one of a select few aerospace companies who have attained this accreditation as validation of our materials testing capabilities and our position as a composite solutions provider. To achieve this standard, Greene Tweed’s CE lab completed a comprehensive audit against the highest standards for special process controls, test completion, and validation. This in-house accreditation adds to Greene Tweed’s responsiveness to new product development requests while expanding production material and customer product certification capabilities. It also